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Medical Device Outsourcing - Coverage Report Q1 2019

Healthcare

Q1 2019

One of the hurdles consistently facing medical device original equipment manufacturers is the significant costs and length of time to design, develop, and secure regulatory clearance for a new product. According to ScienceDirect, a platform for peer-reviewed scholarly literature, the average time-to-market for a medical device falls between three to seven years at a cost of $94.0 million for a high-risk, novel medical device. Consequently, medical device OEMs have turned to the MDO industry to support faster and more efficient design, development, testing, and regulatory processes. OEMs are more than ever realizing that implementing a strong regulatory and compliance strategy early in the development process is of paramount importance to accelerating time to market. Capstone Headwaters is also seeing this play out in merger and acquisition activity with an uptick in regulatory related and testing/validation deals completed in 2018.